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FDA 510(k)

gel-e Bandage

K-Number: K172010 · 2017-12-07

ApplicantGel-E, Inc. (Formerly Remedium Technologies, Inc.)
Decision Date2017-12-07
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

gel-e Bandage is a medical device manufactured by Gel-E, Inc. (Formerly Remedium Technologies, Inc.). It received FDA 510(k) clearance on 2017-12-07 under approval number K172010. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gel-e Bandage?

gel-e Bandage is a medical device that received FDA 510(k) clearance on 2017-12-07. It is manufactured by Gel-E, Inc. (Formerly Remedium Technologies, Inc.). The 510(k) number is K172010.

When was gel-e Bandage approved by the FDA?

gel-e Bandage received FDA 510(k) clearance on 2017-12-07, under approval number K172010.

What company makes gel-e Bandage?

gel-e Bandage is manufactured by Gel-E, Inc. (Formerly Remedium Technologies, Inc.).

What is the FDA product code for gel-e Bandage?

The FDA product code for gel-e Bandage is KGN.

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K171842Geistlich Wound MatrixGeistlich Pharma AG K172399MicroMatrixAcell, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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